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Last Updated: January 1, 2026

South Africa: These 10 Drugs Face Patent Expirations and Generic Entry in 2026 - 2027

DrugPatentWatch® Estimated Loss of Exclusivity Dates in South Africa

Generic Entry Dates in Other Countries

These estimated drug patent expiration dates and generic entry opportunity dates are calculated from analysis of known patents covering drugs. Many factors can influence early or late generic entry. This information is provided as a rough estimate of generic entry potential and should not be used as an independent source. The methodology is described in this blog post.

Summary: South Africa: These 10 Drugs Face Patent Expirations and Generic Entry in 2026 - 2027

Tradename Ingredient Estimated Entry Opportunity Date
EMBEDA morphine sulfate; naltrexone hydrochloride 2026-06-19
ESBRIET pirfenidone 2026-09-22
VIZAMYL flutemetamol f-18 2027-08-30
LASTACAFT alcaftadine 2026-03-31
INVOKAMET XR canagliflozin; metformin hydrochloride 2027-12-03
INVOKAMET canagliflozin; metformin hydrochloride 2027-12-03
>Tradename >Ingredient >Estimated Entry Opportunity Date

Details: South Africa: These 10 Drugs Face Patent Expirations and Generic Entry in 2026 - 2027

When can EMBEDA (morphine sulfate; naltrexone hydrochloride) generic drug versions launch?

Generic name: morphine sulfate; naltrexone hydrochloride
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 19, 2026
Generic Entry Controlled by: South Africa Patent 200,810,501

EMBEDA is a drug marketed by Alpharma Pharms. There are nine patents protecting this drug and four Paragraph IV challenges.

This drug has seventy-four patent family members in twenty-three countries.

See drug price trends for EMBEDA.

The generic ingredient in EMBEDA is morphine sulfate; naltrexone hydrochloride. There are twenty-three drug master file entries for this API. Additional details are available on the morphine sulfate; naltrexone hydrochloride profile page.

When can ESBRIET (pirfenidone) generic drug versions launch?

Generic name: pirfenidone
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: September 22, 2026
Generic Entry Controlled by: South Africa Patent 200,802,237

ESBRIET is a drug marketed by Genentech Inc. There are twenty patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has two hundred and sixty-six patent family members in forty-six countries. There has been litigation on patents covering ESBRIET

See drug price trends for ESBRIET.

The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this API. Twenty-three suppliers are listed for this generic product. Additional details are available on the pirfenidone profile page.

When can VIZAMYL (flutemetamol f-18) generic drug versions launch?

Generic name: flutemetamol f-18
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: August 30, 2027
Generic Entry Controlled by: South Africa Patent 201,000,718

VIZAMYL is a drug marketed by Ge Healthcare. There are two patents protecting this drug.

This drug has eighty-two patent family members in twenty-four countries.

See drug price trends for VIZAMYL.

The generic ingredient in VIZAMYL is flutemetamol f-18. One supplier is listed for this generic product. Additional details are available on the flutemetamol f-18 profile page.

When can LASTACAFT (alcaftadine) generic drug versions launch?

Generic name: alcaftadine
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: March 31, 2026
Generic Entry Controlled by: South Africa Patent 200,809,327

Drug Price Trends for LASTACAFT
LASTACAFT is a drug marketed by Abbvie. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has forty-six patent family members in thirty countries. There has been litigation on patents covering LASTACAFT

See drug price trends for LASTACAFT.

The generic ingredient in LASTACAFT is alcaftadine. There are six drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the alcaftadine profile page.

When can INVOKAMET XR (canagliflozin; metformin hydrochloride) generic drug versions launch?

Generic name: canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: December 03, 2027
Generic Entry Controlled by: South Africa Patent 200,903,941

Drug Price Trends for INVOKAMET XR
INVOKAMET XR is a drug marketed by Janssen Pharms. There are four patents protecting this drug.

This drug has two hundred and twenty patent family members in forty-five countries. There has been litigation on patents covering INVOKAMET XR

See drug price trends for INVOKAMET XR.

The generic ingredient in INVOKAMET XR is canagliflozin; metformin hydrochloride. There are twenty-one drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the canagliflozin; metformin hydrochloride profile page.

When can INVOKAMET (canagliflozin; metformin hydrochloride) generic drug versions launch?

Generic name: canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: December 03, 2027
Generic Entry Controlled by: South Africa Patent 200,903,941

Drug Price Trends for INVOKAMET
INVOKAMET is a drug marketed by Janssen Pharms. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and seventy-one patent family members in forty-eight countries. There has been litigation on patents covering INVOKAMET

See drug price trends for INVOKAMET.

The generic ingredient in INVOKAMET is canagliflozin; metformin hydrochloride. There are twenty-one drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the canagliflozin; metformin hydrochloride profile page.

When can JAKAFI (ruxolitinib phosphate) generic drug versions launch?

Generic name: ruxolitinib phosphate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 13, 2027
Generic Entry Controlled by: South Africa Patent 200,908,826

JAKAFI is a drug marketed by Incyte Corp. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirty-six patent family members in forty-six countries. There has been litigation on patents covering JAKAFI

See drug price trends for JAKAFI.

The generic ingredient in JAKAFI is ruxolitinib phosphate. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the ruxolitinib phosphate profile page.

When can OPSUMIT (macitentan) generic drug versions launch?

Generic name: macitentan
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: August 29, 2026
Generic Entry Controlled by: South Africa Patent 200,902,164

OPSUMIT is a drug marketed by Actelion. There are five patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has ninety-nine patent family members in thirty-four countries. There has been litigation on patents covering OPSUMIT

See drug price trends for OPSUMIT.

The generic ingredient in OPSUMIT is macitentan. There are ten drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the macitentan profile page.

When can PRESTALIA (amlodipine besylate; perindopril arginine) generic drug versions launch?

Generic name: amlodipine besylate; perindopril arginine
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: February 26, 2027
Generic Entry Controlled by: South Africa Patent 200,807,024

PRESTALIA is a drug marketed by Adhera. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty patent family members in twenty-seven countries. There has been litigation on patents covering PRESTALIA

The generic ingredient in PRESTALIA is amlodipine besylate; perindopril arginine. There are fifty drug master file entries for this API. Additional details are available on the amlodipine besylate; perindopril arginine profile page.

When can PROMACTA (eltrombopag olamine) generic drug versions launch?

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: May 03, 2027
Generic Entry Controlled by: South Africa Patent 200,907,710

PROMACTA is a drug marketed by Novartis. There are six patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has one hundred and thirty-four patent family members in forty-one countries. There has been litigation on patents covering PROMACTA

See drug price trends for PROMACTA.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the eltrombopag olamine profile page.

When can SAVAYSA (edoxaban tosylate) generic drug versions launch?

Generic name: edoxaban tosylate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: March 29, 2027
Generic Entry Controlled by: South Africa Patent 201,005,906

Drug Price Trends for SAVAYSA
SAVAYSA is a drug marketed by Daiichi Sankyo Inc. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and one patent family members in thirty-four countries. There has been litigation on patents covering SAVAYSA

See drug price trends for SAVAYSA.

The generic ingredient in SAVAYSA is edoxaban tosylate. There are four drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the edoxaban tosylate profile page.

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: May 04, 2026
Generic Entry Controlled by: South Africa Patent 200,808,361

Drug Price Trends for TRADJENTA
TRADJENTA is a drug marketed by Boehringer Ingelheim. There are eleven patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has four hundred and eighty-six patent family members in forty-five countries. There has been litigation on patents covering TRADJENTA

See drug price trends for TRADJENTA.

The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.

When can TRINTELLIX (vortioxetine hydrobromide) generic drug versions launch?

Generic name: vortioxetine hydrobromide
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 15, 2027
Generic Entry Controlled by: South Africa Patent 200,810,017

Drug Price Trends for TRINTELLIX
TRINTELLIX is a drug marketed by Takeda Pharms Usa. There are ten patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has two hundred and seventeen patent family members in forty-two countries. There has been litigation on patents covering TRINTELLIX

See drug price trends for TRINTELLIX.

The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the vortioxetine hydrobromide profile page.

When can TRELSTAR (triptorelin pamoate) generic drug versions launch?

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 06, 2027
Generic Entry Controlled by: South Africa Patent 200,907,940

TRELSTAR is a drug marketed by Verity. There is one patent protecting this drug.

This drug has forty-seven patent family members in thirty-two countries.

See drug price trends for TRELSTAR.

The generic ingredient in TRELSTAR is triptorelin pamoate. There are three drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the triptorelin pamoate profile page.

When can KORSUVA (difelikefalin acetate) generic drug versions launch?

Generic name: difelikefalin acetate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: November 10, 2026
Generic Entry Controlled by: South Africa Patent 200,903,053

KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug.

This drug has fifty-three patent family members in twenty-seven countries. There has been litigation on patents covering KORSUVA

See drug price trends for KORSUVA.

The generic ingredient in KORSUVA is difelikefalin acetate. One supplier is listed for this generic product. Additional details are available on the difelikefalin acetate profile page.

When can KORSUVA (difelikefalin acetate) generic drug versions launch?

Generic name: difelikefalin acetate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: November 10, 2026
Generic Entry Controlled by: South Africa Patent 200,903,054

KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug.

This drug has fifty-three patent family members in twenty-seven countries. There has been litigation on patents covering KORSUVA

See drug price trends for KORSUVA.

The generic ingredient in KORSUVA is difelikefalin acetate. One supplier is listed for this generic product. Additional details are available on the difelikefalin acetate profile page.

When can OPZELURA (ruxolitinib phosphate) generic drug versions launch?

Generic name: ruxolitinib phosphate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 13, 2027
Generic Entry Controlled by: South Africa Patent 200,908,826

Drug Price Trends for OPZELURA
OPZELURA is a drug marketed by Incyte Corp. There are nineteen patents protecting this drug.

This drug has three hundred and thirty-seven patent family members in forty-nine countries. There has been litigation on patents covering OPZELURA

See drug price trends for OPZELURA.

The generic ingredient in OPZELURA is ruxolitinib phosphate. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the ruxolitinib phosphate profile page.

When can XERMELO (telotristat etiprate) generic drug versions launch?

Generic name: telotristat etiprate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: December 12, 2026
Generic Entry Controlled by: South Africa Patent 200,903,367

XERMELO is a drug marketed by Tersera. There are five patents protecting this drug.

This drug has seventy patent family members in twenty-nine countries.

See drug price trends for XERMELO.

The generic ingredient in XERMELO is telotristat etiprate. One supplier is listed for this generic product. Additional details are available on the telotristat etiprate profile page.

When can AMELUZ (aminolevulinic acid hydrochloride) generic drug versions launch?

Generic name: aminolevulinic acid hydrochloride
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: December 22, 2026
Generic Entry Controlled by: South Africa Patent 200,903,468

AMELUZ is a drug marketed by Biofrontera. There are three patents protecting this drug.

This drug has twenty-nine patent family members in eighteen countries.

See drug price trends for AMELUZ.

The generic ingredient in AMELUZ is aminolevulinic acid hydrochloride. There are six drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the aminolevulinic acid hydrochloride profile page.

When can INPEFA (sotagliflozin) generic drug versions launch?

Generic name: sotagliflozin
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: September 27, 2027
Generic Entry Controlled by: South Africa Patent 200,902,231

Drug Price Trends for INPEFA
INPEFA is a drug marketed by Lexicon Pharms Inc. There are three patents protecting this drug.

This drug has eighty-one patent family members in thirty-three countries.

See drug price trends for INPEFA.

The generic ingredient in INPEFA is sotagliflozin. Additional details are available on the sotagliflozin profile page.

When can OPSYNVI (macitentan; tadalafil) generic drug versions launch?

Generic name: macitentan; tadalafil
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: August 29, 2026
Generic Entry Controlled by: South Africa Patent 200,902,164

OPSYNVI is a drug marketed by Actelion. There are three patents protecting this drug.

This drug has ninety-nine patent family members in thirty-four countries. There has been litigation on patents covering OPSYNVI

See drug price trends for OPSYNVI.

The generic ingredient in OPSYNVI is macitentan; tadalafil. There are ten drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the macitentan; tadalafil profile page.

When can TRIPTODUR KIT (triptorelin pamoate) generic drug versions launch?

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 06, 2027
Generic Entry Controlled by: South Africa Patent 200,907,940

TRIPTODUR KIT is a drug marketed by Azurity. There is one patent protecting this drug.

This drug has forty-seven patent family members in thirty-two countries.

The generic ingredient in TRIPTODUR KIT is triptorelin pamoate. There are three drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the triptorelin pamoate profile page.

When can INVOKANA (canagliflozin) generic drug versions launch?

Generic name: canagliflozin
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: December 03, 2027
Generic Entry Controlled by: South Africa Patent 200,903,941

Drug Price Trends for INVOKANA
INVOKANA is a drug marketed by Janssen Pharms. There are four patents protecting this drug and one Paragraph IV challenge. Five tentatively approved generics are ready to enter the market.

This drug has two hundred and twenty patent family members in forty-five countries. There has been litigation on patents covering INVOKANA

See drug price trends for INVOKANA.

The generic ingredient in INVOKANA is canagliflozin. There are twenty-one drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the canagliflozin profile page.

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